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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 64 Results
productcode LOM PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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PMA
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ARCHITECT AUSAB / Alinity i Anti-HBs ABBOTT LABORATORIES INC P050051 S058 12/14/2023
ARCHITECT CORE-M / Alinity i Anti-HBc IgM Abbott Laboratories P060035 S042 12/14/2023
ARCHITECT CORE / Alinity i Anti-HBc Abbott Laboratories P080023 S044 12/14/2023
ARCHITECT HBsAg Qualitative / Alinity i HBsAg Qual... Abbott Laboratories P110029 S049 12/14/2023
ARCHITECT HBsAg Next Qualitative / Alinity i HBsAg... Abbott Laboratories P210003 S010 12/14/2023
ARCHITECT AUSAB, Alinity i Anti-HBs ABBOTT LABORATORIES INC P050051 S057 12/07/2023
ARCHITECT HBsAg Qualitative/Confirmatory, Alinity ... Abbott Laboratories P110029 S048 12/07/2023
ARCHITECT HBsAg Next Qualitative/Next Confirmatory... Abbott Laboratories P210003 S009 12/07/2023
LIAISON® XL MUREX Anti-HBc and LIAISON® XL MUREX C... DiaSorin Inc. P180038 S016 11/08/2023
LIAISON® XL MUREX Anti-HBs, LIAISON® XL MUREX Cont... DiaSorin Inc. P180039 S015 11/08/2023
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